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Leqvio Side Effects

Generic name: inclisiran

Medically reviewed by Last updated on May 14, 2023.

Note: This document contains side effect information about inclisiran. Some dosage forms listed on this page may not apply to the brand name Leqvio.

Applies to inclisiran: subcutaneous solution.

Serious side effects of Leqvio

Along with its needed effects, inclisiran (the active ingredient contained in Leqvio) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking inclisiran:

Less common

  • Trouble breathing

Other side effects of Leqvio

Some side effects of inclisiran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • difficulty in moving
  • muscle pain or stiffness
  • pain in the joints

Less common

  • Bladder pain
  • bloody or cloudy urine
  • chest tightness
  • cough producing mucus
  • diarrhea
  • difficulty, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • pain in the arms or legs

For Healthcare Professionals

Applies to inclisiran: subcutaneous solution.


Very common (10% or more): Serum hepatic transaminase elevations, elevated ALT (up to 19.7%), elevated AST (up to 17.2%)

In clinical studies, more frequent elevations of serum hepatic transaminases between greater than 1 times the upper limit of normal (1 x ULN) and up to 3 x ULN in patients receiving this drug compared to placebo. ALT and AST elevations were reported in 19.7%, and 17.2%, respectively, of patients using this drug compared with 13.6% and 11.1%, respectively, of patients on placebo; these elevations did not progress to exceed the clinically relevant threshold of 3 x ULN, were asymptomatic, and were not associated with adverse reactions or other evidence of liver dysfunction.


Very common (10% or more): Diabetes mellitus (up to 11.6%)


Common (1% to 10%): Injection site reactions (included injection site pain, injection site erythema, injection site rash)[Ref]

Injection site reactions occurred in 8.2% of patients and included injection site reaction (3.1%), injection site pain (2.2%), injection site erythema (1.6%), and injection site rash (0.7%). These reactions were mild or moderate in severity, transient, and resolved without sequelae.[Ref]


Common (1% to 10%): Arthralgia, back pain, pain in extremity[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


Common (1% to 10%): Bronchitis, nasopharyngitis, cough, dyspnea[Ref]


Common (1% to 10%): Diarrhea[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache


Common (1% to 10%): Angina pectoris


Common (1% to 10%): Anti-drug antibodies[Ref]

Frequently asked questions


1. "Product Information. Leqvio (inclisiran)." Novartis Pharmaceuticals (2022):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.